País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
Rottapharm Ltd
ESTRADIOL HEMIHYDRATE
25 mg/24ho Milligram
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-07-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0868/007/001 Case No: 2051977 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROTTAPHARM LTD DAMASTOWN INDUSTRIAL PARK, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product EPIESTROL - SEPTEM 25 MICROGRAMS/24 HOURS TRANSDERMAL PATCH The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 01/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/09/2009_ _CRN 2051977_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EPIESTROL -Septem 25 micrograms/24hours Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One transdermal patch contains: 2.58 mg of estradiol hemihydrate equivalent to 2.5 mg estradiol/11.25 cm 2 delivering 25 µg of estradiol in 24 hours. Excipient(s): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Each patch is transparent, colourless, slightly opaque with an elliptical shape and a printed identification code, and covered by a rectangular, transparent protective liner. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy Llegiu el document complet